Regulatory agencies need to be tough
It is alarming that unsubstantiated stem cell-based treatments for Covid-19 are cropping up everywhere. Bioethicist Leigh Turner, of the University of Minnesota, recently flagged stem-cell-based “therapies” in a leading journal, Stem Cell Stem.
Turner worries that users of these so-called treatments for Covid-19 will be harmed by products that haven't been rigorously tested, or that they'll forgo measures like physical distancing as they believe the product will shield them from being infected.
He notes a business in Colorado selling mesenchymal stem cell exosomes “for patients that need to boost their immune system” or who want “additional defence against the virus” for US$3,000. Clinics in Alabama, Arizona, California, Delaware, Florida and Pennsylvania have made similar claims; some advertise stem cell therapies as a preventive step while others claim it can repair damage from Covid-19.
Other companies offer biobanking of one’s own stem cells. “Having a frozen line of one's own personal mesenchymal stem cells could prove life-saving should someone become a victim of the current viral pandemic,” a clinic in Alabama states. A caveat: Your own stem cells might not assist you. Nothing is guaranteed and the storage fee is very costly.
Stem cells are certainly an interesting path for Covid-19 treatment — but they have not yet proved effective under well-designed and rigorously conducted clinical trials. During this unprecedented crisis, it is ethical to provide people with evidence-based therapies, but not with unproven cures. By making it appear that these stem cell treatments have already been validated by credible clinical studies, these businesses are mispresenting the public. They are scammers.
Currently, data is either anecdotal or based on poorly designed investigations. While cell-based therapies in the treatment of Covid-19 are indeed promising, they must first be thoroughly investigated in well-designed clinical trials. These will establish whether there is concrete evidence that supports using stem cell products as established treatments.
Unfortunately, the limited preliminary clinical studies that have been performed with stem cells are not enough to support commercialising these interventions. On an optimistic note, multiple studies are in progress with 90 clinical trials using mesenchymal stem cells.
Meanwhile, professional organisations such as the International Society for Stem Cell Research and the International Society for Cell & Gene Therapy have warned that such advertising is ethically irresponsible.
While it is pleasing to see scientific opposing unsubstantiated Covid-19 therapies, it is also necessary for the US Food and Drug Administration (FDA) and other regulatory agencies to crack down on these unproven and unlicensed clinics. The FDA has issued “untitled letters” to clinics advertising unproven stem cell interventions; letters like this are used for violations that do not fulfil the threshold of regulatory significance for a warning letter.
The Federal Trade Commission (FTC) has just revealed it has sent warning letters to another 35 clinics. In all, the Commission has sent about 160 of these letters to companies and individuals. They direct clinics to instantly cease making claims that their products can treat or cure Covid-19 and update the Commission within 48 hours about the steps they have taken to address the agency's concerns.
The letters also warn that if the false claims continue, the Commission may seek an injunction and a court order requiring a refund to be made to consumers.
In Australia, the Therapeutic Goods Authority (TGA) recently tightened its regulation on advertising cell products directly to consumers. Haematopoietic stem cell transplants for autoimmune diseases, blood disorders and cancers are presently the only approved uses of stem cells in the country. The FDA has sent warning letters to companies providing Covid-19 treatments, including one company based in Perth, Western Australia.
Making it appear as if shonky stem cell treatments have been validated by credible clinical studies misleads the public and could be very dangerous. Harsh enforcement measures are needed in the US and in Australia.
Dr Patrick Foong is a law lecturer at Western Sydney University. His research interest lies in bioethics and health law.
stem cell therapies